Vol.33, Suppl ]]V 2006 新薬の開発,審査,承認
Development, Evaluation and Approval of New Drugs
目 次
序 文iii 竹内正弘(Masahiro Takeuchi)
Stephen W. Lagakos
Faculty Membersiv-xix 
Opening Remarks 1-2柴 忠義(Tadayoshi Shiba)
Congratulatory Remarks3-4川原 章(Akira Kawahara)
Welcoming Address5-6Declan P. Doogan
Session 1 : Performance of New Drug Research and Development in Japan and
   its International Competitiveness
 Declan P. Doogan
  Clinical Research to be Delivered to Patients9-17笹月健彦(Takehiko Sasazuki)
  Japanese Pharmacutical Industry from the Viewpoint of National Policy19-28渡邉 徹(Toru Watanabe)
  International Competitiveness of the Japanese Pharmaceutical Industry29-35小田切宏之(Hiroyuki Odagiri)
  The Plan for Promotion of Biotechnology as a Science Technology in Industry37-44多喜田圭二(Keiji Takita)
  International Competitiveness of the Japanese Clinical Trials on Cost and
45-58島谷克義(Katsuyoshi Shimatani)
  Panel Discussion59-70 
Session 2 : New Challenges-Enhancement of Productivity and Performance-71-118Chairperson:
 井村裕夫(Hiroo Imura)
  The Impact of Critical Path Initiative on R&D in Japan73-83竹内正弘(Masahiro Takeuchi)
  The Development and Use of Translational Models and Biomarkers in
   Clinical Development of New Medicines
85-99Jeremy Gale
  Innovation of Web-based Registration System for an International Collaboration
   Study on Clear Cell Carcinoma of the Ovary
101-8藤原恵一(Keiichi Fujiwara)
  Panel Discussion109-18 
Session 3 : New Challenges-Disease Areas-119-57Chairperson:
 高久史麿(Fumimaro Takaku)
  Vaccination Therapy for Alzheimer's Disease121-9田平 武(Takeshi Tabira)
  Prevention of Cardiovascular Diseases:
   Aggresive Management of Cardiovascular Risk Factors
131-40山田信博(Nobuhiro Yamada)
  Investigator Initiated Trial (IIT):
   Future for IIT from the Past Experience
141-6寺岡 あきら(Akira Teraoka)
  Panel Discussion147-57 
Session 4 : New Challenges-Innovative Study Design, along with Mathematical
   Approch and Simulation of Global/Regional Clinical Studies-
 Marvin Zelen
  Design Considerations in Global Clinical Trials:
   Keys in Newly Disigning of Global Studies and Validation Study
   Designs of Novel Biomarkers
161-6 H.M. James Hung
  Design Issues in Anti-infective Trials:
   Opportunities and Challenges for Innovative Study Designs
167-74Daphne Lin
  Explore and Develop Modeling/Simulation: "RALES" Design
   Kitasato-Harvard-Pfizer-Hitachi Project
175-89宇野 一(Hajime Uno)
  Data Mining Approach to Improve the Accuracy of AE Analysis:
   Establishment of Key Medical Institute Network, Collection of AE
   Information and its Analysis
191-7小島千枝(Chie Kojima)
  Panel Discussion199-215 
Session 5 : Regulatory-based Dialogues-Global Trials, Asian Trials-217-85Chairperson:
 竹内正弘(Masahiro Takeuchi)
  A Trial to Assess Ethnicity and Hint on How to Design Global/Asian Studies219-32Keith D. Wilner
  Regulatory Aspect of Asian Trials
   Regulatory-based Dialogues in Taiwan for Global and Asian Trials
233-8Herng-Der Chern
  Regulatory Perspectives and Clinical Trial Situation in Korea239-44In-Jing Jang
  Regulatory-based Dialogues: Regulatory Aspect of Asian Trials245-55Yang-Tong Foo
  Regulatory Aspect of Asian Trials: Whither (and Whether) Bridging?257-63小林 健(Ken Kobayashi)
  Challenge of a Global Trial and an Asian Trial265-74仁平新一(Shin-ichi Nihira)
  Panel Discussion275-85 
Session 6 : Regulatory-based Dialogues-Performance of Regulatory Review-287-333Chairperson:
 小野俊介(Shunsuke Ono)
  Opening Remarks at Session 6289-90小野俊介(Shunsuke Ono)
  Current Status and Future Perspectives of Clinical Trial Consultation and
   NDA Review Performance
291-9宇山佳明(Yoshiaki Uyama)/TD>
  Proposal from industry eg. Quality, Performance and Training301-6高橋希人(Kihito Takahashi)
  Review System for NDA Approval in the USA and Japan and
   their Performance of Review
307-14安積織衛(Orie Asaka)
  Eary Approval and Launch of New Drugs: Dissolution of Drug Lag315-9成川 衛(Mamoru Narukawa)
  Panel Discussion321-33 
Conclusion & Closing Remarks335-42 
  Conclusion337-40Lee-Jen Wei
  Closing Remarks341-2竹内正弘(Masahiro Takeuchi)

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